Applies to mogamulizumab: intravenous solution.

Serious side effects of Mogamulizumab

Along with its needed effects, mogamulizumab may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking mogamulizumab:

More common

• Black, tarry stools
• bladder pain
• bleeding gums
• blood in the urine or stools
• cloudy urine
• blurred vision
• body aches or pain
• burning, dry, or itching eyes
• burning, itching, and pain in hairy areas, pus at the root of the hair
• burning, numbness, tingling, or painful sensations
• chest pain
• chills
• cough
• cracked lips
• decreased frequency or amount of urine
• diarrhea
• difficult or labored breathing
• difficult, burning, or painful urination
• difficulty in swallowing
• discharge, excessive tearing
• dizziness
• drowsiness
• dry mouth
• ear congestion
• fainting
• fast, slow, or irregular heartbeat
• fever
• flushed, dry skin
• frequent urge to urinate
• fruit-like breath odor
• headache
• increased hunger
• increased thirst
• increased urination
• itching, skin rash
• joint pain, stiffness, or swelling
• loss of appetite
• loss of voice
• lower back, side, or stomach pain
• mood or mental changes
• muscle and bone pain
• muscle spasms (tetany) or twitching seizures
• nasal congestion
• nausea
• nervousness
• pale skin
• pinpoint red spots on the skin
• pounding in the ears
• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
• runny nose
• skin blisters
• sneezing
• sore throat
• sores, ulcers, or white spots on the lips, tongue, or inside the mouth
• stomach pain
• swelling of the face, fingers, lower legs, or feet
• tenderness
• tightness in the chest
• trembling
• troubled breathing with exertion
• unexplained weight loss
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting
• warmth on skin
• weakness in the arms, hands, legs, or feet
• weight gain

Less common

• Burning or stinging of the skin
• earache
• painful cold sores or blisters on the lips, nose, eyes, or genitals
• redness or swelling in the ear

Rare

• Chest discomfort
• dilated neck veins
• extreme tiredness or weakness
• irregular breathing
• pain or discomfort in the arms, jaw, back, or neck

Incidence not known

• Dark urine
• general tiredness and weakness
• light-colored stools
• upper right abdominal pain
• yellow eyes and skin

Other side effects of Mogamulizumab

Some side effects of mogamulizumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Constipation
• decreased appetite
• discouragement
• falls
• feeling sad or empty
• irritability
• loss of interest or pleasure
• thinning or loss of hair
• trouble concentrating
• trouble sleeping

For Healthcare Professionals

Applies to mogamulizumab: intravenous solution.

Hematologic

Very common (10% or more): Thrombocytopenia (14%), anemia (12%)^[Ref]

Immunologic

Common (1% to 10%): Candidiasis, urinary tract infection, folliculitis, pneumonia, otitis, herpesvirus infection

Postmarketing reports: Hepatitis B virus reactivation^[Ref]

Local

Very common (10% or more): Infusion reaction (33%)^[Ref]

Musculoskeletal

Very common (10% or more): Musculoskeletal pain (e.g., back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, pain in extremity) (22%)

Common (1% to 10%): Muscle spasm^[Ref]

Ocular

Common (1% to 10%): Conjunctivitis^[Ref]

Metabolic

Very common (10% or more): Albumin decreased (34%), calcium decreased (30%), uric acid increased (29%), phosphate decreased (27%)

Common (1% to 10%): Hyperglycemia, hyperuricemia, hypomagnesemia, weight gain, weight loss, anorexia^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression^[Ref]

Oncologic

Uncommon (0.1% to 1%): Tumor lysis syndrome

Respiratory

Very common (10% or more): Upper respiratory tract infection (e.g., laryngitis viral, nasopharyngitis, pharyngitis, rhinitis, sinusitis, upper respiratory tract infection, viral upper respiratory tract infection) (22%), cough (11%)

Common (1% to 10%): Dyspnea^[Ref]

Other

Very common (10% or more): Fatigue (31%), pyrexia (17%), edema (16%)

Common (1% to 10%): Chills, fall^[Ref]

General

The most common adverse reactions (reported in 20% or more of patients)

were rash (including drug eruption), infusion related reactions, fatigue, diarrhea, upper respiratory tract infection. and musculoskeletal pain. Adverse reactions reported in 10% or more of patients included skin infection, pyrexia, nausea,

edema, thrombocytopenia, headache, constipation, mucositis, anemia, cough, and hypertension.^[Ref]

Nervous system

Very common (10% or more): Headache (14%)

Common (1% to 10%): Dizziness, peripheral neuropathy^[Ref]

Renal

Common (1% to 10%): Renal insufficiency^[Ref]

Cardiovascular

Very common (10% or more): Hypertension (10%)

Common (1% to 10%): Arrhythmia

Uncommon (0.1% to 1%): Myocardial infarction, myocardial infarction, cardiac failure

Postmarketing reports: Stress cardiomyopathy^[Ref]

Dermatologic

Very common (10% or more): Rash (dermatitis [e.g., allergic, atopic, bullous, contact, exfoliative, infected); drug eruption [e.g., palmoplantar keratoderma]; rash [e.g., generalized, macular, maculopapular, papular, pruritic, pustular]; skin reaction [e.g., toxic skin eruption]) (35%), drug eruption (24%), skin infection (e.g., cellulitis, dermatitis infected, erysipelas, impetigo, infected skin ulcer, periorbital cellulitis, skin bacterial infection, skin infection, staphylococcal skin infection) (22%)

Common (1% to 10%): Xerosis, alopecia^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (28%), mucositis (e.g., aphthous stomatitis, mouth ulceration, mucosal inflammation, oral discomfort, oral pain, oropharyngeal pain, stomatitis) (17%), nausea (16%), constipation (13%)

Common (1% to 10%): Vomiting, abdominal pain^[Ref]